Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)

NCT06922994 | Recruiting Phase 2 DMC

• 3 other identifiers: SEARCHPNRR-MCNT2-2023-123769782024-514643-28-00
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 5

Brief Summary

The goal of this clinical trial is to learn if Atorvastatin 80 mg is effective to avoid functional right ventricular deterioration in patients affected by Arrhythmogenic Cardiomyopathy. It will also learn about the safety of Atorvastatin 80 mg in this type of patients. The main questions it aims to answer are:

1. 1.Does Atorvastatin 80 mg prevent worstening of the right ventricular functioning?
2. 2.Does Atorvastatin 80 mg prevent the worsening of electric, morphological and biomarkers deterioration?
3. 3.What medical problems do participants have when taking Atorvastatin 80 mg?
4. 4.Take Atorvastatin 80 mg or a placebo every day for 18 months;
5. 5.Visit the clinic at the enrollment and after 2, 4, 9 and 18 months for checkups and tests;
6. 6.Make a phone call for safety check after 12, 15 and 19 months since the enrollment;
7. 7.Fill out psychological questionnaires

Conditions

Arrhythmogenic Cardiomyopathy

Keywords

Atorvastatin; Strain; Disease progression risk; Arrhythmias

Outcome Measures

Primary Outcomes (1)

• Efficacy of Atorvastatin in avoiding functional right ventricular deterioration

  Variation of right ventricular free wall longitudinal strain measured by echocardiography after 18 months respect to baseline (%)

  From enrollment to the end of treatment at 18 months

Secondary Outcomes (31)

• Safety of Atorvastatin treatment

  From enrollment to 1 month after the end of treatment (19 months)

• Efficacy of Atorvastatin in avoiding morphological deterioration (ventricular volumes)

  From enrollment to the end of treatment (18 months)

• Efficacy of Atorvastatin in avoiding morphological deterioration (wall thickness )

  From enrollment to the end of treatment (18 months)

• Efficacy of Atorvastatin in avoiding morphological deterioration (cardiac function )

  From enrollment to the end of treatment (18 months)

• Efficacy of Atorvastatin in avoiding arrhythmic deterioration (premature ventricular contractions)

  From enrollment to the end of treatment at 18 months

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

Atorvastatin arm will be composed by 51 patients affected by Arrhythmogenic Cardiomyopathy.

Drug: Atorvastatin 80 mg/day

Placebo

PLACEBO COMPARATOR

Placebo arm will be composed by 51 patients affected by Arrhythmogenic Cardiomyopathy.

Drug: Placebo atorvastatin

Interventions

Atorvastatin 80 mg/day DRUG

Atorvastatin 80mg/day will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy

Atorvastatin

Placebo atorvastatin DRUG

One tablet of placebo will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be at least 18 years of age, at the time of signing the informed consent
• Participants affected by Arrhythmogenic Cardiomyopathy as defined by task force criteria

You may not qualify if:

• Known hypersensitivity to atorvastatin or any of the excipients
• Moderate or severe liver disease
• Muscle disease
• Left ventricular ejection fraction \<35%
• Congestive heart failure defined by the New York Heart Association (NYHA) as class III or IV.
• Known cardiomyopathy of other origin: post ischemic, hypertrophic, idiopathic dilated, restrictive; known moderate-to-severe mitral or aortic valvulopathy; pulmonary hypertension; congenital cardiac abnormalities
• Hypercholesterolemic patients that require the use of lipid lowering drugs.
• Heart transplantation
• Estimated life expectancy of less than 2 years
• Any other medical condition that, in the judgment of the investigator, places the patient at risk or makes the patient unreliable or limits the patient's ability to complete the study
• Potent CYP3A4 modifiers such as Erythromycin, Clarithromycin Azole antifungals, Protease inhibitors , Gemfibrozil, Ciclosporin, Danazol
• Fusidic acid (drug for bacterial infections)
• Hepatitis C antivirals as telaprevir, boceprevir, glecaprevir/pibrentasvir and ledipasvir/sofosbuvir combination
• Any other lipid lowering drugs such as Statins, Cholesterol absorption inhibitors, Bile acid sequestrants , PCSK9 inhibitors, Adenosine triphosphate-citrate lyase inhibitors , Fibrates, Omega-3 fatty acid ethyl esters
• Drugs primary indicated as antioxidants

Sponsors & Collaborators

• Università Politecnica delle Marche: collaborator
• Centro Cardiologico Monzino: lead
• Federico II University: collaborator
• Ospedali dei Colli: collaborator

Study Sites (5)

Fondazione I.R.C.C.S. Policlinico San Matteo

Pavia, PV, 27100, Italy

RECRUITING

Università Politecnica delle Marche

Ancona, 60126, Italy

RECRUITING

Centro Cardiologico Monzino IRCSS

Milan, 20138, Italy

RECRUITING

AORN - Ospedali dei Colli

Napoli, 80131, Italy

RECRUITING

Università degli Studi di Napoli Federico II

Napoli, 80138, Italy

NOT YET RECRUITING

Related Publications (1)

• Sommariva E, Stadiotti I, Casella M, Catto V, Dello Russo A, Carbucicchio C, Arnaboldi L, De Metrio S, Milano G, Scopece A, Casaburo M, Andreini D, Mushtaq S, Conte E, Chiesa M, Birchmeier W, Cogliati E, Paolin A, Konig E, Meraviglia V, De Musso M, Volani C, Cattelan G, Rauhe W, Turnu L, Porro B, Pedrazzini M, Camera M, Corsini A, Tondo C, Rossini A, Pompilio G. Oxidized LDL-dependent pathway as new pathogenic trigger in arrhythmogenic cardiomyopathy. EMBO Mol Med. 2021 Sep 7;13(9):e14365. doi: 10.15252/emmm.202114365. Epub 2021 Aug 2.

  PMID: 34337880 BACKGROUND

MeSH Terms

Conditions

Sprains and Strains; Arrhythmias, Cardiac

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Wounds and Injuries; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Claudio Tondo

  Centro Cardiologico Monzino IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Sommariva

CONTACT

+39 0258002752; elena.sommariva@cardiologicomonzino.it

Claudio Tondo

CONTACT

+39 0258002275; claudio.tondo@cardiologicomonzino.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicenter, prospective, randomized, clinical study: Atorvastatin 80mg/day or placebo will be administered for 18 months to 102 ACM patients, and the endpoints will be tested.

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: April 11, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)